Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under... | NCT01223456

Studies
Safety and Efficacy Study of ONGLYZA (Saxagliptin) Under Conditions of Actual Use

NCT01223456

Sponsor

AstraZeneca

Status

Terminated

Last Update Posted

Oct 8, 2013Estimated

Enrollment

542Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

Not provided

Countries

Philippines

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Inability to recruit adequate number of patients within the specified time period.

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Oct 14, 2010

First Submission Date that Met QC Criteria

Oct 18, 2010

First Posted Date

Oct 19, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2013

Last Update Posted Date

Oct 8, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This post marketing surveillance study aims to monitor the safety and efficacy of ONGLYZA under conditions of actual use in patients who are diagnosed with diabetes mellitus type 2 and are prescribed ONGLYZA by their physician.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

542Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse events observed during the treatment duration		Upon enrollment and initiation of Saxagliptin up to 14 days post follow-up
Clinical Response determined by cure rate		Up to three (3) months after initiation of treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of Type 2 Diabetes Mellitus
Prescribed Saxagliptin by patient's attending physician

Exclusion Criteria:

Known allergic or serious adverse reaction to Saxagliptin
Pregnant or breastfeeding patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

several private and government hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milagros Tan, MD	AstraZeneca Philippines	Study Director
Emmanuel Arca, MD	AstraZeneca Philippines	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Batangas	Batangas		Philippines
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided